Manager, Regulatory Affairs – Electromechanical Devices (hybrid)

Job description

Position Summary The Manager, Regulatory Affairs is a working Manager who assists in development and execution of Global Regulatory Strategies and Plans to assure that new products and changes to existing products are developed in line with the global registration requirements of targeted countries in support of the electromechanical devices in the Infusion Systems business. Develop high quality US, EU MDR and global regulatory submissions that continue to build credibility with regulatory authorities/notified bodies. Obtain expedient registration for assigned products. Maintain registrations of existing products in compliance with applicable regulations. Essential Duties & Responsibilities: - Develops regulatory strategies for development projects, design changes and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by global regulatory authorities. - Directs submission related activities by leading the team and motivating the staff to successfully execute regulatory strategies. Makes independent judgments and decisions based on regulations and professional experience. Ensures alignment with Regulatory Management as appr...